Glucose Measuring Device Integrated Into A Holster For A Personal Area Network Device

ABSTRACT

A glucose meter module integrated into a holster device that can securely accommodate another device such as a portable server device or an insulin pump is described. The glucose measuring module and the health device communicate with each other by a short range wireless modality. In the case in which the accommodated device is a server, such as personal digital assistant or cell phone, the device stores data in a memory, displays data on a visual display, and can wirelessly transmit such data to other devices within a personal area network. In the case where the accommodated device is a cell phone, the phone can further transmit data to remote sites. In the case where the accommodated device is an insulin pump, wirelessly received data are stored in a memory, are available for visual display on the insulin pump, and can be incorporated into the electronic processes that regulate the performance of the pump.

RELATED APPLICATIONS

This is a divisional application of pending U.S. patent application Ser.No. 10/891,327 filed Jul. 14, 2004, which claims priority to U.S.Provisional Application No. 60/487,808 filed Jul. 15, 2003, thedisclosures of each of which are incorporated herein by reference intheir entirety for all purposes.

FIELD OF THE INVENTION

The present invention relates to glucose monitoring devices. Moreparticularly, the present invention relates to a glucose sensor moduleintegrated into a holster that can accommodate another device, andfurther, to a method by which the glucose sensor module and theaccommodated device wirelessly communicate with each other.

BACKGROUND

The number of diagnosed cases of diabetes continues to increase in theU.S. and throughout the world, creating enormous economic and publichealth consequences. One area in which recently developed technologieshave been able to improve the standard of care has been in themaintenance of tight control over the blood glucose levels. It is wellknown that if a diabetic patient's blood glucose values are maintainedwithin the normal range of from about 80 milligrams per deciliter(mg/dL) to about 120 mg/dL, the physiologically damaging consequences ofunchecked diabetes can be minimized.

Recent technological and commercial development in the two areas ofglucose monitoring and of insulin administration have each contributedsignificantly to improving the ability of diabetic people to maintainbetter control over their blood glucose level, and thereby enhance theirquality of life.

With better blood glucose information, diabetic patients can betterexercise tight control of their blood glucose level through a variety ofmeans, including diet, exercise, and medication. A common type ofglucose measuring device is represented by hand-held electronic meterswhich receive blood samples via enzyme-based “test strips”. In usingthese systems, the patient lances a finger or alternate body site toobtain a blood sample, the sample is applied to the strip, the strip isinserted into a port in the meter housing where it engages the meter'sinternal electronics, and the electronics convert a current generated bythe enzymatic reaction in the test strip to a blood glucose value. Theglucose value is then typically displayed on the meter's liquid crystaldisplay (LCD), which is generally relatively large in size in order toaccommodate the eyesight capability of older adults and diabetic people,who often have deteriorating vision.

Some diabetic patients require insulin administration in order tomaintain tight control of their glucose level. Insulin administration tothese insulin-dependent patients has traditionally been byself-injection, but a more recently available technology is representedby insulin pumps. These pump devices offer significant therapeutic valueover self injection, as the pumps deliver insulin in a morephysiological manner, with measured doses of insulin being infusedslowly, over an extended period of time. Further, the rate at whichinsulin is delivered can be programmed to follow standard orindividually-modified protocols, to give the user even better glucosecontrol over the course of a day. Insulin pumps have commerciallyevolved to become small in size, which offers easier portability andunobtrusiveness, and with electronic advances, they have evolved tobecome more fully-featured, and thus capable of enhanced andindividualized performance. These various advantages in terms of healthcare quality and user convenience have supported the growth of theinsulin pump market.

It has been recognized that combining the newer technologies of insulinadministration with the newer technologies of glucose measurement couldsignificantly improve user convenience, resulting in a greater abilityto comply with frequent testing, and greater ability to effectindividually appropriate schedules of insulin administration.

Such an integrated combination of a glucose measuring device and insulinpump is shown in U.S. Pat. No. 5,665,065, which teaches the inclusion ofa mechanism for measuring blood glucose within the housing of an insulinpump. While the advantages of such a glucose measuring/insulin pumpcombinations has been known for many years, in fact, no such device hasbecome commercially available. Various practical and market-basedfactors may contribute to the absence of a combination device in themarket. Insulin pumps, though expensive, have become well establishedand stabilized in the market; and pump users tend to remain with theirinitial choice. Glucose meters, in contrast, are presently evolving morequickly and are inexpensive for users; indeed they are often provided tousers by manufacturers without charge, as a loss leader in an overallbusiness strategy. At least in part as a consequence of the low price,glucose meter users have lower brand loyalty, and will switch amongbrands. As another consequence, there is intense manufacturing costpressure on glucose meters, which, in turn, encourages efficient productdesign by the meter manufacturers. From the perspective of a pumpmanufacturer in designing such a physically integrated combinationdevice, the manufacturer would need to commit to a particular bloodglucose measuring technology in the face of the concern that suchtechnology could become less competitive or even obsolete during thenormal life of the pump product.

It is known that hand-held glucose meters can advantageously bemanufactured to include short range wireless communication capability,through which data from the glucose sensor can be transmitted to anotherhealth device, such as a computer, cell phone, or a personal digitalassistant (PDA); such wireless communication between two portabledevices is shown in the PCT publication WO03005891A1. This wireless datatransfer relieves the glucose sensor user of the need to record suchdata by hand, and allows for accumulation of data points within a largerdatabase for longer term health monitoring and intervention. In spite ofthe benefits of wireless communication, the inconvenience of handlingseparate devices to achieve the patient's singular goal of maintainingglucose control remains unsolved by wireless communication alone.

Devices that provide for secure personal portability of variouscommunication and health-related electronic devices, and ease of usewhile being carried are also well known. Holsters and cases forelectronic devices that attach to belts or other articles of clothingare never far from where mobile telephones are being sold, and aredescribed in U.S. Pat. Nos. 5,664,292 and 5,833,100, and 6,081,695.Similarly, U.S. Pat. No. 5,472,317 describes an apparatus that providesfor a belt-clip mounting for a medication infusion pump.

In view of these various problematic factors associated with the actualphysical integration of a glucose measuring device with an insulin pump,it would be desirable to provide an insulin pump user the benefits andperformance of functionally combined glucose measuring device andinsulin pump. Such a combined device would desirably be in a portableconfiguration that, in fact, maintains physical distinctness of thedevices, gets past the market-based barriers that accompany physicalintegration, and yet offers a combination which for all practicalpurposes is used as a single integrated device. It would be furtherdesirable for this functionally integrated device to be fully enabled tointeract with other devices within a personal area network.

SUMMARY OF THE INVENTION

In view of the foregoing, in accordance with one embodiment of thepresent invention, there is provided a glucose monitoring devicehousing, comprising a holster unit, a glucose sensing module integrallydisposed on the holster unit, where the holster unit is configured tosubstantially receive a server device, the server device configured towirelessly communicate with the glucose sensing module.

The server device may include a blood glucose monitoring device.Alternatively, the server device may include one or more of an insulinpump, a personal digital assistant, a mobile telephone, and a portablegaming unit.

The server device may be configured to receive one or more data from theglucose sensing module, the one or more data including one or more datarelated to a detected blood glucose level.

The glucose sensing module may include a test strip port configured toreceive a test strip.

The glucose sensing module may be shaped substantially elongate.

In one embodiment, the glucose sensing module may be configured totransmit data to the server device when the server device issubstantially positioned within the holster unit.

The holster unit may include in one embodiment a belt clip portion, anda device clasping portion mechanically coupled to the belt clip portion.

The belt clip portion may be mechanically coupled to the device claspingportion by a spring biased connector unit.

Further, the glucose sensing module may be integrally disposed on one ofthe belt clip portion and the device clasping portion.

The glucose sensing module may include a test strip port configured toreceive a test strip.

The device clasping portion of the holster unit may be configured toreceive the server device such that the server device is in physicalcontact with the device clasping portion. Moreover, the server devicemay be securely positioned substantially within the device claspingportion of the holster unit.

Additionally, in one embodiment, each of the glucose sensing module andthe server device may include a communication port for datacommunication.

Indeed, the glucose sending module communication port and the serverdevice communication port each may include one of an infrared port, aBluetooth enabled communication port, and a Wi-Fi enabled communicationport.

The server device may include in one embodiment one or more of an outputunit, and an input unit, where the output unit may include one or moreof a display unit and an audio output unit.

The display unit in this case may include one of a liquid crystaldisplay (LCD) unit, a plasma display unit, and a touch-sensitive displayunit, and further, wherein the audio output unit includes an outputspeaker.

Also, the input unit may include one or more of an input button, and atouch-sensitive input unit integrated with the output unit.

Additionally, the output unit may be configured to output one or more ofan image data, a video data, and an audio signal, in response to apredetermined event.

The predetermined event in one embodiment may include one or more of aninput command generated by the input unit and a detection of a glucosesensing module signal.

A method of providing a glucose monitoring device housing in accordancewith another embodiment of the present invention includes the steps ofproviding a holster unit, integrally disposing a glucose sensing moduleon the holster unit, configuring the holster unit to substantiallyreceive a server device, and configuring the server device to wirelesslycommunicate with the glucose sensing module.

In a further embodiment, the server device may include one or more of ablood glucose monitoring device, an insulin pump, a personal digitalassistant, a mobile telephone, and a portable gaming unit.

The method may further include the step of configuring the server deviceto receive one or more data from the glucose sensing module, the one ormore data including one or more data related to a detected blood glucoselevel.

Also, the method may additionally include the step of providing a teststrip port on the glucose sensing module, the test strip port configuredto receive a test strip.

Indeed, the method may also include the step of configuring the glucosesensing module to transmit data to the server device when the serverdevice is substantially positioned within the holster unit.

A data management system for managing health related data in accordancewith still another embodiment of the present invention includes apersonal area network, a client device configured for data communicationin the personal area network, and a server device configured tocommunicate with the client device in the personal area network, wherethe client device is configured to transmit one or more health relateddata to the server device over the personal area network, and the serverdevice is configured to generate one or more health management signalsbased on the received one or more health related data.

The client device may include a client device wireless communicationport for data communication, and the server device includes a serverdevice wireless communication port for data communication.

Further, each of the client device wireless communication port and theserver device wireless communication port may include one of an infraredport, a Bluetooth enabled port, and a Wi-Fi communication port.

Moreover, the client device may include a blood glucose meter, andfurther, where the health related data includes a blood glucose leveldata.

The server device may include a blood glucose monitoring deviceconfigured to generate the one or more health management signals basedon the blood glucose level data received from the blood glucose meter,where the health management signals includes one or more of an audioalert signal, a vibration alert signal, and a graphical display signal.

The blood glucose monitoring device may in one embodiment be configuredto generate an alert signal for output when the received blood glucoselevel data is determined to be beyond a predetermined range.

Also, the predetermined range may substantially establish an impendinghyperglycemic state and an impending hypoglycemic state.

In the manner described above, in accordance with one embodiment of thepresent invention, there is provided a glucose monitoring and responsesystem that includes a glucose meter module, operating within a personalarea network as a client device, integrated into a holster apparatustypically clipped or loop-attached to a belt or other article ofclothing worn by a diabetic person, the holster being configured so asto be able to securely accommodate another health device such as aportable server device or an insulin pump. Communication between theglucose measuring module and the responding health device may beperformed by a wireless modality, for example using infrared (IR),Bluetooth, or Wi-Fi (801.11g, 801.11b, or 801.11a) protocols.

In one embodiment, the accommodated device may include a server, such asa personal digital assistant or cell phone, where the accommodateddevice may be configured to store data in a memory, display data on avisual display, and may wirelessly transmit such data to other deviceswithin a personal area network (PAN), as well as send data to remotesites via the global system for mobile communications (GSM). In anotherembodiment where the health device includes an insulin pump, thewirelessly received data may be stored in a memory, and may be availablefor visual display on the insulin pump, as well as incorporating intothe selection of appropriate protocols that regulate the performance ofthe pump.

The glucose measuring module in one embodiment of the present inventionmay include glucose measuring circuitry for enzymatic electrochemicaldetection of glucose in a blood sample. The module, by including aholster accommodation for a device with which it wirelesslycommunicates, may be configured to establish a functional systemintegration in spite of physical distinctness of the two major systemcomponents. Cost and size of the holster-integrated glucose meter may beminimized by reliance on the fully meter-functional display and controlspresent on the holster-accommodated device, and the absence of theredundant visual display and redundant control buttons on the glucosemeter.

More particularly, in accordance with one embodiment of the presentinvention, there is provided a glucose sensing and insulin deliverysystem which includes a glucose sensor module, an insulin pump includinga visual display, a holster apparatus into which the glucose sensormodule is integrated and which holster is configured to hold the insulinpump, and a wireless data communication system for transmitting databetween the glucose sensor module and the insulin pump.

In another embodiment, the holster apparatus may include a belt-clipportion and a device clasping portion. Moreover, the glucose sensormodule may be integrated into the device-clasping portion of the holsterapparatus. Alternatively, the glucose sensor module may be integratedinto the belt-clip portion of the holster apparatus.

The wireless data communication system may include an infraredtransceiver in the glucose sensor module and an infrared transceiver insaid insulin pump. Additionally, the wireless data communication systemmay include a Bluetooth-enabled transceiver in the glucose sensor moduleand a Bluetooth-enabled transceiver in the insulin pump.

Furthermore, the glucose sensing and insulin delivery system may includea single visual display. Alternatively, the glucose sensor module maynot include a visual display.

In addition, the insulin pump may include a housing, where the housingincludes control buttons mounted in the housing.

Also, control unit may be provided for controlling the operation of theglucose module, where the control unit may include control buttonsmounted on the insulin pump.

In accordance with another embodiment of the present invention, there isprovided a glucose sensing system comprising a glucose sensor moduleenabled to wirelessly communicate within a personal area network, asecond personal area network communication-enabled device including avisual display, and a holster apparatus into which the glucose sensormodule is integrated and which holster is configured to hold the secondpersonal area network device.

The second personal area network communication-enabled device mayinclude an insulin pump. Alternatively, the second personal area networkcommunication-enabled device may include a cell phone.

These and other features and advantages of the present invention will beunderstood upon consideration of the following detailed description ofthe invention and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described by reference to the figures, whereinlike reference numerals and names indicate corresponding structurethroughout the several views.

FIG. 1A illustrates a glucose measuring module integrated into thedevice-clasping portion in accordance with one embodiment of the presentinvention;

FIG. 1B illustrates a belt-clasping portion with a glucose measuringmodule integrated thereto in accordance with another embodiment of thepresent invention;

FIG. 2A illustrates a glucose measuring module integrated into thedevice-clasping portion in accordance with another embodiment of thepresent invention;

FIG. 2B illustrates the belt-clasping portion with a glucose measuringmodule integrated therewith in accordance with another embodiment of thepresent invention;

FIG. 3 illustrates a cut away perspective view where the IR transceiverports of the glucose measuring module and the held device, respectively,are aligned for transmission of IR data in accordance with oneembodiment of the present invention;

FIG. 4 illustrates an exploded view of a swivel-enabled and detachableholster apparatus, a holding button, a device carrying case, and a heldserver device in accordance with one embodiment of the presentinvention;

FIG. 5 is a block diagram illustrating data signal flow between devicesof a wireless system in accordance with one embodiment of the presentinvention;

FIG. 6 is a block diagram of a glucose meter client device as shown inFIG. 3 in accordance with one embodiment of the present invention;

FIG. 7 is a block diagram of a server device such as an insulin pump, asshown in FIG. 3 in accordance with one embodiment of the presentinvention; and

FIG. 8 is a pictorial view showing a client device and server deviceswithin a personal area network in accordance with one embodiment of thepresent invention.

DETAILED DESCRIPTION

FIG. 1A illustrates a glucose measuring module integrated into thedevice-clasping portion in accordance with one embodiment of the presentinvention. Referring to the Figure, there are shown two main componentsof the holster apparatus, a belt-clip portion 101 and device-claspingportion 103, which includes a glucose sensing module 102, a clientdevice within the larger context of networked devices to be furtherdescribed below. The glucose-sensing module is generally elongate andpen-shaped, as has been described in U.S. Patent Application entitledGlucose Measuring Device for Use in Personal Area Network filed Jun. 4,2004, assigned to TheraSense, Inc., of Alameda Calif., the assignee ofthe present invention, and the disclosure of which is incorporatedherein by reference for all purposes. More specifically, as shown in theFigure, the glucose sensing module 102 may be integrally molded into thelarger contours of the device clasping portion of the holster apparatus,and situated vertically on the outer aspect of one of the two claspingarms 104 of device clasping portion 103.

At the base of the glucose sensing module 102 is located a test stripport 105, wherein test strips are inserted after having been contactedwith a blood sample. Alternatively, glucose sensing module 102 can beconfigured to accept test strips before they have been contacted with ablood sample. Other configurations for the placement of the glucosesensing module within the clasping portion of the holster are possiblethat would meet the basic requirement that the module, and moreparticularly the test strip port 105 within the module, be readilyaccessible to the user. The two holster mechanical components, thebelt-clip portion 101 and the device-clasping portion 103, may be joinedby a spring-biased connector (not shown) which causes the belt-clip topress toward the device-clasping portion, in order to grip a belt orarticle of clothing worn by a user, and thus to secure the apparatus.

FIG. 1B illustrates a belt-clasping portion with a glucose measuringmodule integrated thereto in accordance with another embodiment of thepresent invention. Referring to the Figure, there is shown a perspectiveview of a belt-clip portion of another embodiment of the holsterapparatus into which the glucose sensing module 102 has been integrated.As noted in the description above in conjunction with FIG. 1A, theglucose-sensing module 102 is generally elongate and pen-shaped, but inthis embodiment it has been molded into the larger contours of thebelt-clip portion 101 of the holster apparatus, and is situatedhorizontally across the top of the upper aspect thereof. Otherconfigurations for the placement of the glucose sensing module arepossible that would meet the basic desire that the module, and moreparticularly the test strip port 105 within the module be readilyaccessible to the user. Because of the constraints of the generallyelongate profile of the glucose sensing module 102 as a whole, as wellas the elongate profiles of test strips and the test strip port 105, thetest strip port 105 in one embodiment of the present invention ispreferably located at one of the two ends of the glucose sensing module102 (see FIGS. 1A-1B and 2A-2B.). The analog “front end” circuitryassociated with measuring the small electrochemical currents from teststrips 101 is located near the strip port 105, and is sensitive toelectrical interference. It is advisable, therefore, to situate thewireless link antenna of the glucose sensing module 102 at a such adistance from the strip port end that such wireless transmissioninterference does not occur. In operation, in accordance with oneembodiment, the holster apparatus may either be worn by the user whilethe test strip is inserted into the test strip port 105, oralternatively, the holster apparatus may be removed from the user'sbelt, for example, when inserting the test strip into the test stripport 105 and conducting a glucose measurement.

FIG. 2A illustrates a glucose measuring module integrated into thedevice-clasping portion in accordance with another embodiment of thepresent invention. Referring to the Figure, there are shown the two maincomponents of the holster apparatus, a belt-clip portion 201 anddevice-clasping portion 203, which includes a glucose sensing module202, a client device within the larger context of networked devices asdescribed in further detail below. This embodiment illustrates featuresthat provide both for swiveling of the held device with respect to therelatively fixed orientation of the holster when secured to a belt, aswell as an ability to quickly engage and disengage the held serverdevice (see FIG. 4) from the holster. The feature providing these formsof functionality is a button-holding box 206, which includes a U-shapedslot 205. Fitting into this U-shaped slot 205 is a complementarybroadened holding button 407 (see FIG. 4) that is attached to the backof the held server device 411 (see FIG. 4), thereby securing the heldserver device 411 to the holster.

Referring back to FIG. 2A, the glucose-sensing module 202, generallyelongate and pen-shaped, may be molded into the larger contours of thedevice clasping portion 203 of the holster apparatus, and may besituated vertically on the outer aspect of one of the two sides of theclasping portion 203 of the holster, or on one of the sides of thebutton-holding box 206. Located at the base of the glucose sensingmodule 202 may be a test strip port 204, into which test strips areinserted before or after having been contacted with a blood sample.Other configurations for the placement of the glucose sensing modulewithin the clasping portion of the holster are possible that would meetthe basic requirement that the module, and more particularly the teststrip port 204 within the module be readily accessible to the user. Thetwo major mechanical components of the holster, the belt-clip portion201 and the device-clasping portion 203, are typically joined by aspring-biased connector (not shown) which causes the belt-clip to presstoward the device-clasping portion 203, in order to grip a belt or anarticle of clothing worn by a user, and thus to secure the apparatus.

FIG. 2B illustrates the belt-clasping portion with a glucose measuringmodule integrated therewith in accordance with another embodiment of thepresent invention. Referring to the Figure, there is shown a perspectiveview of a belt-clip portion 201 of another embodiment of the samegeneral type of holster apparatus as seen in FIG. 2A, into which theglucose sensing module 102 has been integrated. As discussed above inconjunction with FIG. 2A, the glucose-sensing module 102 is generallyelongate and pen-shaped, but has been molded into the larger contours ofthe belt-clip portion 201 of the holster apparatus, and situatedhorizontally across the top of the upper aspect of the belt-clip portion201 of the holster apparatus. Within the scope of the present invention,other configurations for the placement of the glucose sensing module arepossible that would meet the basic desire that the module, and moreparticularly the test strip port 204 within the module be readilyaccessible to the user.

Moreover, other forms of the belt-clip portion of the holster may becompatible with the various embodiments shown herein and within thescope of the above-described and illustrated embodiments of the presentinvention. The clip, for example, may be made of bent metal or moldedplastic, the clasping pressure of the spring, as described above, inthese alternative embodiments being instead provided by the spring biasinherent in the bent metal or molded plastic. Metal clips may also becovered with fabric and/or padding material. Alternatively, thebelt-clip portion could also be fabricated as a loop, constructed fromvarious materials (fabric, synthetics, leather), into which the belt ofthe user is threaded, and the loop could also make use of Velcro®-typehook and loop connections.

FIG. 3 illustrates a cut away perspective view where the IR transceiverports of the glucose measuring module and the held device, respectively,are aligned for transmission of IR data in accordance with oneembodiment of the present invention. Referring to the Figure, theinfrared (IR) modality is shown as being used to transmit data between aclient device and the server device 409 (FIG. 4). Successfultransmission by the IR may be facilitated by a physical alignment of thetransmitting and receiving data ports, as shown herein. In this explodedand partially cutaway figure, the inner aspect of a clasping arm 104 ofthe clasping portion 103 of a holster is shown. From thisinside-looking-out and transparent perspective, the outline of theclient device, or glucose sensing module 102 on the outer aspect of theclasping arm 104 is seen. Within that outline of the glucose sensingmodule can also be seen the wireless transceiver port 301 of the glucosesensing module, which faces inward, toward the accommodated serverdevice 411.

Exploded rightward for visibility is the server device 411, or insulinpump in this depiction, that may be held by the holster apparatus. Onthe front aspect of the housing of this device, the LCD 409 andinterface control keys 410 can be seen. The front aspect housing of thedevice 411 is for purpose of illustration rendered as partiallytransparent so as to make visible the transceiver port 302 of thedevice, located on a side wall of the housing, facing outward toward theclasping arm 104, and more specifically, toward transceiver 301 of theglucose monitor 102. It can thus be seen that when the insulin pump orportable server device 411 is contained within the holster, the twotransceiver ports 301 (of the client device) and 302 (of the serverdevice), are directly aligned together, a configuration that assuressuccessful transmission of data by IR.

FIG. 4 illustrates an exploded view of a swivel-enabled and detachableholster apparatus, a holding button, a device carrying case, and a heldserver device in accordance with one embodiment of the presentinvention. Referring to the Figure, there is shown on the left side ofthe figure is a holster device, swivel-enabled and detachable, as inFIG. 3. Moving rightward, a holding button 407 is depicted. The holderbutton 407 is attached to the back of device carrying case 408. Thebutton 407 is seen in this embodiment to include two basic elements (around insertion piece and a square backing nut), connected by a spacerbar (not shown). The round insertion piece slips into the U-shaped slotof the button holder box, and secures the device carrying case 408 tothe holster.

The server device in the illustrated case includes an insulin pump withan LCD display 409 and control interface keys 410. The carrying case 408is a component of holster devices and which allows for the secureholding of a device, the device itself being unencumbered by specificattachment elements. A carrying case can be combined with the hereindescribed holster apparatus, whether it is of the variety depicted inFIG. 1, or in FIG. 2 (swivel-enabled, detachable), as well as othervariations of holsters based on two basic mechanical elements, abelt-clip portion and a device-clasping portion within the scope of thepresent invention. In the variations containing a case, thedevice-clasping portion actually secures the case, and the case, inturn, secures the held device. The case itself generally constructedfrom one or more types of fabric, such as cloth, plastic, or leather,and is custom fitted to the contours of the held device.

FIG. 5 is a block diagram illustrating data signal flow between devicesof a wireless system in accordance with one embodiment of the presentinvention. Referring to the Figure, a wireless system 500 for movingdata among devices in the context of a personal area network andconstructed according to one embodiment of the present invention isshown. In one embodiment, the test strip 501 electrically communicateswith client device 502, which wirelessly communicates with server device504, such as by two-way radio frequency (RF) contact, infrared (IR)contact, or other known wireless connections 503. Optionally, serverdevice 504 may also communicate with other devices such as dataprocessing terminal 505 by direct electronic contact, via RF, IR, orother wireless connections.

Test strip/sensor unit 501 is an electrochemical analyte test strip,such as the blood glucose test strip described in U.S. patentapplication Ser. No. 09/434,026 filed Nov. 4, 1999 entitled “SmallVolume In Vitro Analyte Sensor and Methods”, assigned to TheraSense,Inc., of Alameda, Calif., the assignee of the present invention, and thedisclosure of which is incorporated herein by reference for allpurposes. The test strip 501 is mechanically received in a test stripport 105, 204, 404 (of the embodiments shown in FIGS. 1, 2, and 4,respectively) of a client device 502, similar to a hand-held bloodglucose meter as described in the aforementioned patent applicationentitled Small Volume In Vitro Analyte Sensor and Methods. In oneembodiment, client device 502 is constructed without a user interface ordisplay to keep the size and cost of device 502 to a minimum. Clientdevice 502 can be powered by a single AA or AAA size battery, and cantake a pen-like form that is integrally molded into the largerconfiguration of a holster, as shown in FIGS. 1 and 2.

Referring back to FIG. 5, the client device 502 wirelessly communicateswith server device 504, preferably using a common standard such as802.11 or Bluetooth RF protocol, or an IrDA infrared protocol. Theserver device 504 may include another portable device, such as aPersonal Digital Assistant (PDA), a cell phone, a pump for a medicationsuch as insulin, and a portable gaming unit, for example, (and as shownby some of the examples in FIG. 8). In one embodiment, the server device504 includes a display, such as a liquid crystal display (LCD), as wellas an input device, such as control buttons, a keyboard, mouse ortouch-screen. With this configuration, the user can control clientdevice 502 via interaction with the user interface(s) of server device504, which in turn interacts with client device 102 across wireless link503.

The server device 504 may also communicate with a data processingterminal 505, such as for sending glucose data from devices 502 and 504,and/or receiving instructions or an insulin pump protocol from a healthcare provider via the data processing terminal 505. Examples of suchcommunication include a PDA 504 synchronizing data with a personalcomputer (PC) 505, a mobile phone 504 communicating over a cellularnetwork with a computer 505 at the other end, or an insulin pump 504communicating with a computer system 505 at a physician's office.

FIG. 6 is a block diagram of a glucose meter client device as shown inFIG. 3 in accordance with one embodiment of the present invention.Referring to FIG. 6, internal components of the client device 502 suchas a blood glucose meter of one embodiment is shown. User input 602 ofdata or instructions, via keys or control buttons is shown as an option,but can also be eliminated to reduce size and cost of client device 502.In this case, data or instructional input can be provided via the serverdevice 504 held in the holster (see FIG. 7 and description below). Theglucose meter housing may contain any glucose sensing system of the typewell known in the art that can be configured to fit into a smallprofile. Such a system can include, for example, the electrochemicalglucose strip and meter sensing system sold by TheraSense, Inc. ofAlameda, Calif. under the FreeStyle® brand, or other strip and meterglucose measuring systems. The housing may thus encompass the sensorelectronics and a strip connector, which connector is accessed via atest strip port opening in the housing. The housing will typically alsoinclude one or more batteries.

FIG. 7 is a block diagram of a server device such as an insulin pump, asshown in FIG. 3 in accordance with one embodiment of the presentinvention. Referring to FIG. 7, internal components of server device 504of one embodiment are shown. Note that a redundant test strip interface701 can be provided if desired for receiving test strips 501. Serverdevice 504 can be a proprietary unit designed specifically for use withblood glucose meters, or can be a generic, multipurpose device such as astandard PDA. An example of a similar device designed for blood glucosetesting is disclosed in U.S. Pat. No. 6,560,471 issued May 6, 2003 tothe TheraSense, Inc. of Alameda, Calif., the assignee of the presentinvention, entitled “Analyte Monitoring Device and Methods of Use”, thedisclosure of which is incorporated herein by reference for allpurposes. Note also the presence of user input 703, which would occurthrough user manipulation of buttons or keys. There is two-way data flowbetween devices 502 and 504, and thus data or instructional inputapplied through the held device 504 can be seamlessly applied tocontrolling the operation of a client device (a glucose meter, for aspecific example).

As noted in the discussion above of the client device in conjunctionwith FIG. 6, one embodiment of the present invention include the“displayless” glucose meter unit on the display of a separate device inorder to minimize the complexity and cost of the meter unit. The glucosemeter user “reads” and interacts with the meter via the larger displayunits within his or her personal area network, all of which can besynchronized as they interact and communicate with the wireless enabledmeter. When the glucose meter is used, the sequences through which theuser must “step” to complete the test are readily viewed on the largerdisplay units (for example, by entering the calibration code, promptingapplication of the sample). At the same time the meter unit issimplified, smaller and less expensive to manufacture.

Additionally, control buttons that are found on typical glucose meterscan be eliminated, saving additional size and cost, since the user canrely on the user in out features of the server device instead. It isexpected that the simplified, wireless enabled meters integrated into adevice holster, as described herein, may ultimately become inexpensiveenough to make them disposable after a specified number of uses,permitting the producer to routinely upgrade as appropriate.

Further, the system permits the user to include security coding at anytime the meter unit accesses a display device, so that the user's dataare secure, such that, when the “client” meter of one embodiment of thepresent invention is used, the system requires the user to enter anidentity code in order to verify that the person handling the meter isindeed an authorized user. In an alternate embodiment, it is possiblefor the system to permit more than one user if the meter owner sodesires.

While the glucose sensing module does not include a large or expensivedisplay, it may nevertheless be advantageous to include some ability toadvise the user of a glucose level which is determined when the moduleis used as a “stand-alone” unit. For example, the module could include avery low cost, small three digit LCD display. Alternatively, the modulecould include light emitting diode (LED) indicator lights (for example,red for out of desired range, green for within desired range). Otherpossibilities include a red LED for below range, a green LED for withinrange, and a yellow LED for above range, or a column of LEDs or anelectroluminescent strip (similar to those used on common batteries toindicate battery life) to indicate approximate or relative glucoselevels.

FIG. 8 is a pictorial view showing a client device and server deviceswithin a personal area network in accordance with one embodiment of thepresent invention. More specifically, FIG. 8 shows examples of thedevices to and from which the meter (client device 801) of oneembodiment of the present invention can communicate. Such devices may bea part of an individual's personal area network and each device isenabled to communicate via short range wireless communication link withevery other device. Laptop computers 803 and handheld computers 802, aswell as printers 804 can be so enabled and will provide displays andprintouts valuable as records for the diabetic. Telephones such ascellular telephones 805 and regular land-line telephones 808 will alsobe enabled in this fashion and can be used for displaying glucose dataas well as further enabled to transmit the data over larger networks viaGSM protocols (as for the cellular telephones 805). Many of thesedevices can assist the diabetic by responding to glucose levels byproviding alarms, or suggesting that action be taken to correct ahypoglycemic or hyperglycemic condition, or by summoning necessarymedical assistance.

Diabetics are well aware of the risks involved in driving when glucoselevels are out of range and particularly when they are too low. Thus,for example, the navigation computer in the diabetic's vehicle 806 couldbecome part of the personal area network and would download glucose datafrom the meter when the diabetic enters the vehicle 806. For the sake ofsafety, the car computer system could be programmed to require that thediabetic perform a glucose test before driving, and more specificallythe car could be disabled until the diabetic performs a blood glucosetest and the result is in an appropriate range. Other possible devicesfor communication with the client device 801 may include a television807, a gaming device 809, and a refrigerator 810.

In this manner, in accordance with the embodiments of the presentinvention, there is provided a glucose monitoring system resulting fromthe functional combination of a holster-integrated glucose measuringdevice and a second device accommodated within the holster. The holsteritself includes a belt-clip portion and a device-clasping portion; theglucose monitor can be integrated into either portion. Variousembodiments provide for an ability for the belt-clip and device-claspingportions to swivel with respect to each other, and to detach from eachother. In the embodiments where the belt-clip portion and claspingportion do not detach, the clasping portion provides for a quickattachment/detachment of the held server device.

Various other modifications and alterations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments. It isintended that the following claims define the scope of the presentinvention and that structures and methods within the scope of theseclaims and their equivalents be covered thereby.

1. An integrated medical device, comprising: a housing including areceiving section, and a data transmission unit for transmitting glucoserelated data; and an infusion pump configured to detachably couple tothe receiving section of the housing, the medical device including acommunication unit for communicating with the data transmission unit,the infusion pump further including an output unit for one or more ofthe received glucose related data or therapy related data; wherein atleast a portion of the infusion pump is received within the receivingsection of the housing when the infusion pump is coupled to the housing.2. The device of claim 1 wherein the infusion pump coupled to thehousing for a portable integrated device.
 3. The device of claim 1wherein the housing includes a strip port disposed thereon.
 4. Thedevice of claim 3 wherein the housing includes a blood glucose meter foranalyzing a blood sample received via the strip port.
 5. The device ofclaim 4 wherein the transmitted glucose related data corresponds to theanalyzed blood sample.
 6. The device of claim 1 when the infusion pumpcommunication unit is configured to receive the glucose related datafrom the data transmission unit only when the infusion pump is coupledto the housing.
 7. An integrated device, comprising: a housing having nouser interface, the housing including a blood glucose meter and a firstdata communication unit; and a medication infusion device including auser interface unit and a second data communication unit, the userinterface unit configured to output one or more data associated with ablood glucose level or medication infusion, the second datacommunication unit configured to communicate with the first datacommunication unit; wherein a portion of the housing is configured tocontain the medication infusion device when the medication infusiondevice is detachably coupled to the housing.
 8. The device of claim 7wherein the first data communication unit is configured to transmit tothe second data communication unit one or more signals associated with ablood sample analyzed by the blood glucose meter.
 9. The device of claim7 wherein the second data communication unit is configured receive oneor more signals associated with a blood sample analyzed by the bloodglucose meter only when the medication infusion device is coupled to thehousing.
 10. The device of claim 7 wherein the housing and themedication infusion device form a single portable integrated unit whenthe housing contains the medication infusion device.
 11. The device ofclaim 7 wherein the first data communication unit and the second datacommunication unit are each configured for one or more of infraredcommunication, RF communication, Bluetooth communication, Wi-Ficommunication, cellular communication, or wired communication.
 12. Thedevice of claim 7 wherein the housing portion includes a claspingportion for retaining the medication infusion device when coupled to thehousing.
 13. The device of claim 7 wherein the housing is displayless.14. The device of claim 7 wherein calibration information is provided tothe blood glucose meter using the user interface unit of the medicationinfusion device.
 15. The device of claim 7 wherein the user interfaceunit of the medication infusion device is configured to control, atleast in part, the operation of the blood glucose meter.
 16. The deviceof claim 7 wherein the housing is configured to be secured to a belt oran article of clothing of a user.